DIRECT (“DIabetes REsearCh for patient straTification”), a consortium funded by the Innovative Medicines Initiative (IMI), has announced the launch of a 45 million Euro project focusing on a stratification of patients with diabetes.
Scientists and clinicians working in academia have joined forces with the pharmaceutical industry to tackle the current bottlenecks in diabetes drug development and to develop a personalized medicines approach to treatment of ‘type 2 diabetes’ (T2D) with either existing or novel therapies.
Leading European experts from 21 academic institutions and four pharmaceutical research organizations officially launched the DIRECT project on February 1st.
The project is supported by the Innovative Medicines Initiative (IMI), a unique Public Private Partnership (PPP) between European Union and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations / EFPIA).
The EU contributes to this PPP a total of one billion Euro over ten years, which is matched in-kind by the EFPIA member companies.
Type 2 diabetes is a pandemic disease which currently affects 285 million people worldwide and which is anticipated to affect 439 million people worldwide by 2030.
Whilst Type 2 diabetes is usually assumed to be one condition, the DIRECT consortium believes that it can be stratified into different subtypes that may progress differently or be treated differently to other subtypes.
The aim of the consortium is the discovery, development and application of biomarkers, or tests, that predict who gets diabetes, whose diabetes deteriorates rapidly after diagnosis and who responds well or poorly to diabetes therapy.
This will result in the development of new drugs and the better targeting of existing drugs in order to improve outcomes of patients with diabetes.
DIRECT is a unique collaboration of leading European academic groups and pharmaceutical companies in the diabetes field in Europe.
Around 150 researchers operating in nine different scientific work packages will collect phenotypic and genomic data from pre-diabetic and diabetic patients, diabetic patients treated with anti-diabetic drugs and by bariatric surgery.
More than 100.000 samples of well-characterized T2D patients will be provided by the consortium partners to apply novel methods in systems biology and pathway analysis with the goal of identifying biomarkers that predict the incidence of diabetes, the rapid deterioration of glycaemia or the response/non-response to therapy.
The identified biomarker candidates will then be validated in prospective clinical trials for later use as new diagnostics or prognostics as well as in the development of novel therapeutics.
“It has been fascinating to see how quickly a strong consortium has been formed, building bridges between the very different worlds of academic and the pharmaceutical industry research organizations,” said Hartmut Ruetten from Sanofi.
Ewan Pearson from University of Dundee and Veikko Koivisto from Eli Lilly, the coordinators of DIRECT, agree: “There is no doubt that strong collaboration between diabetes clinicians and scientists in academia, and the experts in biomarker and drug discovery, and drug trials, in the pharmaceutical industry will result in improvements in patient care, and that’s what DIRECT is all about - better, personalized treatment for patients with diabetes.”